Research
CRIS

The UHC CRIS program includes a select group of more than 30 UHC academic health centers (AHCs) committed to reengineering clinical research processes to more effectively compete in the rapidly changing clinical research marketplace. Services include:

• Clinical Research Benchmarking Projects

  Benchmarking projects are conducted to compare the important measures of clinical research quality and efficiency among members and their integrated delivery networks. This includes data such as number of days from protocol receipt by investigator to IRB approval, number of days to obtain a signed financial agreement, and number of patients promised compared to number enrolled.

  To establish levels of best practice and to identify areas in need of reengineering within organizations, participants receive annual benchmarking reports with data blinded by institution.

  To obtain more information about CRIS Benchmarking Projects, contact Lynne Danekas.

• Preferred Provider for UHC CRIS-Managed Multicenter Clinical Trials

  Participants in CRIS are contacted as preferred sites for UHC-managed clinical trials.

  CRIS participants that have a commitment to provide quality clinical research and that have established standards of practice based on benchmarking data are given additional priority status in the site-selection process. UHC is currently managing multicenter research projects funded by drug or medical device manufacturers using CRIS participants as study sites. Emphasis is placed on networking physicians for clinical research within their integrated health care delivery networks.

  To obtain more information about UHC CRIS-Managed Multicenter Clinical Trials, contact Lynne Danekas.

• Clinical Investigator Networks

  CRIS has developed clinical investigator networks, which are promoted to industry sponsors for large-scale clinical studies. Four networks have been initiated in the areas of psychiatry, gastroenterology, pulmonary/critical care, and rheumatology. Plans are currently under way to develop additional networks to meet industry pipeline and market share needs.

  CRIS also provides support to the network physicians by assisting with investigator-initiated research activities, such as NIH grants and other collaborative research initiatives.

  To obtain more information about CRIS Clinical Investigator Networks, contact Sharon Hudson.

• Annual Educational Forum

  Participants in CRIS are encouraged to send two representatives to the annual educational forum without paying registration fees. Forum sessions may include best practice modeling from benchmarking projects, strategic plan development, implications of regulatory changes for AHCs, case studies of successful reengineering activities, guidelines for establishing a new office of clinical research, effective industry relations techniques, and networking opportunities with industry sponsors of clinical research.

  To obtain more information about the CRIS Annual Educational Forum, contact Sharon Hudson.

• UHC Clinical Research & Investigator Services Directory of Participating Academic Medical Centers

  Developed and distributed to research sponsors through direct mail, convention contacts, and inquiries, the directory lists participating members and associate members, their capabilities, and contact information for their central clinical trials offices.

  To obtain a copy of the CRIS Directory, contact Sharon Hudson.

• Clinical Research Reports

  The CRIS Clinical Research Reports will cover topics such as creating optimal organizational structures for managing clinical research, successful research collaboration with partners in integrated delivery networks, implications of gene therapy clinical trials, optimizing technology transfer, liability coverage issues, improving patient recruitment, the value of clinical research, and central clinical trials offices. Reports will be published annually.

  To obtain more information about CRIS Clinical Research Reports, contact Sharon Hudson.

• UHC CRIS Good Clinical Practice - The Investigator

  This customized, self-instructional software program provides Web-based training and education related to the clinical trials process. Three self-assessments are available to measure the user's level of understanding of the clinical trials process. The software is also an expert resource for referencing up-to-date and applicable clinical research regulations and procedural obligations regarding the conduct of clinical studies. The software is available to CRIS institutions only as a benefit of program participation.

  To obtain more information about UHC CRIS Good Clinical Practice - The Investigator software, contact Sharon Hudson.

• Standardization Projects to Improve the Clinical Research Process

  Standardization projects have been developed to reduce the time necessary to approve clinical research contracts. Master Clinical Research Agreements for CRIS AHCs are being developed with major pharmaceutical and device companies to improve the timeliness of the contracting process.

  An IRB facilitation program has been established to facilitate the IRB review process at CRIS institutions. Study protocols and informed consent documents are pre-reviewed to shorten the timeline to IRB approval to 30 days for CRIS participants.

  Future projects may include establishing minimum elements in clinical and financial data management systems and associate member research collaboration agreements.

  To obtain more information about CRIS Standardization Projects, contact Lynne Danekas.

• Internet Server for UHC/CRIS Participants

  CRIS has established Internet listservers to facilitate communication among CRIS staff and CRIS participants for sharing ideas and trends and collaboration on proposed studies, including special listservers for CRIS Strategy and Project Management Contacts, Clinical Investigator Networks, CRIS Committees, and Investigational Drug Service Departments. Using these servers, CRIS staff share industry trends, regulation alerts, and AHC case studies demonstrating best practices to help all CRIS participants to become more competitive. In addition, study-specific communications are shared with CRIS participants and clinical research staff investigators.

  To obtain more information about CRIS Internet Listservers, contact Sharon Hudson.

• Local Consultation and Resource Referrals

  CRIS participants needing referrals to experts in areas such as regulatory affairs are referred to those services with which UHC and CRIS staff have had positive experiences.

  UHC CRIS staff and other clinical research experts from participating CRIS institutions are available for on-site consultation. Travel and other expenses are covered by the requesting institution. Requests for consultation may include development of clinical trials office operations, development of local data base(s) for benchmarking data, development of electronic files to facilitate clinical research process, among many others.

  To obtain more information about CRIS Consultation and Resource Referrals, contact Sharon Hudson.

Cost

The annual CRIS participation fee is $7,500 per UHC member or associate member. The fee covers all of the services outlined above, including two free meeting registrations for the annual educational forum.

To obtain more information about enrollment in the CRIS program, contact Sharon Hudson.

For More Information

For additional information about any specific service, contact CRIS staff at the e-mail addresses included in each section, or for overall CRIS program information, contact Peter H. Vlasses, PharmD, 630/954-1788.